ElectrocardiogramNCT06650618
Twelve Leads Electrocardiographic Expressions at Different Body Positioning
An observational study of Electrocardiogram, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Electrical conduction in the heart produces a heartbeat; electrical signals are sent to the heart muscle upon each contraction, causing the heart to pump blood. These electrical impulses are recorded by an electrocardiogram (ECG), which makes it possible to evaluate electrical conduction and cardiac rhythm. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrocardiogram
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants without diagnosed arrhythmia, ischemic heart disease, congestive heart failure or pending for all kinds of heart surgery.
Who may be able to join
- Adults 18~65 years of age
- Fluent in either Taiwanese/Chinese/English.
Who cannot join
- Pregnancy
- Refusal to give informed consent
- Candidate for coronary bypass surgery or valves surgery or other cardiac surgery
- Participants with diagnosed arrhythmia, ischemic heart disease or congestive heart failure
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin Dist, 80756
Kuang-I Cheng, Ph.D, 886-7-3121101 ext. 7035, kuaich@gmail.com
About this study
Electrical conduction in the heart produces a heartbeat; electrical signals are sent to the heart muscle upon each contraction, causing the heart to pump blood. These electrical impulses are recorded by an electrocardiogram (ECG), which makes it possible to evaluate electrical conduction and cardiac rhythm. ECG is a non-invasive technique used to assess pacemaker function and perioperative heart health. Ten electrodes are used in the 12-lead ECG, the gold standard for diagnosing cardiac illness and anatomy, to record the electrical activity of the heart from various perspectives. With wireless data transmission to the cloud, this technology is now included into emergency and ambulance situations, streamlining processes and improving signal quality. The purpose of this observational study is to examine 12-lead electrocardiogram data for better clinical application and diagnosis.
Read the detailed description
The heartbeat is a result of electrical conduction in the heart. The heart's contractions release electrical signals that trigger the heart muscle to pump blood to the lungs and the rest of the body. An electrocardiogram (ECG) records these electrical signals from each heartbeat, allowing for the observation of heart rhythm and the assessment of any abnormalities in electrical conduction. The ECG is a non-invasive monitoring tool used for evaluating heart health throughout the perioperative period and for checking the function of pacemakers. By analyzing the shape, size, and time intervals of these waveforms, ECGs provide visual representations that help healthcare professionals assess conditions related to heart valve diseases.
The 12-lead ECG is considered the gold standard for evaluating cardiac structure and diagnosing various heart conditions. This system consists of twelve leads created from ten electrodes, recording the heart rates electrical activity from different angles in three-dimensional space to understand the condition of various heart regions. Currently, 12-lead ECG machines are widely used in emergency and ambulance settings. They often incorporate integrated electrode patches that replace the traditional ten individual electrode patches, significantly simplifying the process and reducing errors. This integration improves signal transmission and quality compared to traditional ECG leads. Data is transmitted wirelessly, paired with mobile device software, and sent to the cloud to support diagnostic reports.
This study is an observational research project aimed at establishing and analyzing 12-lead ECG data. The goal is to utilize this data for more in-depth diagnostics and to observe its differences and clinical applications.
- Conditions
- Electrocardiogram
- Keywords
- ECG, heart rhythm, electrical conduction
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG change related to position
ECG ST segment elevation or depression might be attributed to varying body postures. The ST segments\' change to baseline will be compared by the investigators.
Measured: through study completion, an average of 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start31 Oct 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectrocardiogramStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzu-Ying Li, Study director, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650618
- Sponsor's protocol ID
- KMUHIRB-E(I)-20240272
- Status last verified
- Aug 2024
- First submitted
- 25 Sep 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical Analysis Plan can be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve Leads Electrocardiographic Expressions at Different Body Positioning
- ClinicalTrials.gov ID
- NCT06650618
- Acronym / sponsor ID
- KMUHIRB-E(I)-20240272
- Conditions
- Electrocardiogram
- Keywords
- ECG, heart rhythm, electrical conduction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electrical conduction in the heart produces a heartbeat; electrical signals are sent to the heart muscle upon each contraction, causing the heart to pump blood. These electrical impulses are recorded by an electrocardiogram (ECG), which makes it possible to evaluate electrical conduction and cardiac rhythm. ECG is a non-invasive technique used to assess pacemaker function and perioperative heart health. Ten electrodes are used in the 12-lead ECG, the gold standard for diagnosing cardiac illness and anatomy, to record the electrical activity of the heart from various perspectives. With wireless data transmission to the cloud, this technology is now included into emergency and ambulance situations, streamlining processes and improving signal quality. The purpose of this observational study is to examine 12-lead electrocardiogram data for better clinical application and diagnosis.
Detailed description
The heartbeat is a result of electrical conduction in the heart. The heart's contractions release electrical signals that trigger the heart muscle to pump blood to the lungs and the rest of the body. An electrocardiogram (ECG) records these electrical signals from each heartbeat, allowing for the observation of heart rhythm and the assessment of any abnormalities in electrical conduction. The ECG is a non-invasive monitoring tool used for evaluating heart health throughout the perioperative period and for checking the function of pacemakers. By analyzing the shape, size, and time intervals of these waveforms, ECGs provide visual representations that help healthcare professionals assess conditions related to heart valve diseases.
The 12-lead ECG is considered the gold standard for evaluating cardiac structure and diagnosing various heart conditions. This system consists of twelve leads created from ten electrodes, recording the heart rates electrical activity from different angles in three-dimensional space to understand the condition of various heart regions. Currently, 12-lead ECG machines are widely used in emergency and ambulance settings. They often incorporate integrated electrode patches that replace the traditional ten individual electrode patches, significantly simplifying the process and reducing errors. This integration improves signal transmission and quality compared to traditional ECG leads. Data is transmitted wirelessly, paired with mobile device software, and sent to the cloud to support diagnostic reports.
This study is an observational research project aimed at establishing and analyzing 12-lead ECG data. The goal is to utilize this data for more in-depth diagnostics and to observe its differences and clinical applications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants without diagnosed arrhythmia, ischemic heart disease, congestive heart failure or pending for all kinds of heart surgery.
Key inclusion criteria (2 listed)
- Adults 18~65 years of age
- Fluent in either Taiwanese/Chinese/English.
Key exclusion criteria (4 listed)
- Pregnancy
- Refusal to give informed consent
- Candidate for coronary bypass surgery or valves surgery or other cardiac surgery
- Participants with diagnosed arrhythmia, ischemic heart disease or congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ECG change related to position
Time frame: through study completion, an average of 30 minutes.
ECG ST segment elevation or depression might be attributed to varying body postures. The ST segments\' change to baseline will be compared by the investigators.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: Yes. Statistical Analysis Plan can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu-Ying Li study director
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrocardiogram, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Ying Li (886-7-3121101 ext. 7035, trustwithtrust@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG change related to position (time frame: through study completion, an average of 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.